A conversation with Craig M. Audet, Vice-President and Head of the US Regulatory Affairs Marketed Products Group at sanofi-aventis, Mark Gaydos, Senior Director, U.S. Regulatory Affairs Marketed Products at sanofi-aventis, and Cynthia Phillips, Sr Dir Labeling and Promotional Compliance at Millennium Pharmaceuticals, about their views on how pharmaceutical companies should handle posts made on social media sites owned or sponsored by them. Of particular interest are posts that mention off-label indications or adverse events. (See guest bios.)

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Background

On November 12-13, 2009, the FDA hosted a public hearing on the "Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools." Over 60 speakers, mostly representing the interests of agencies, made presentations. FDA will continue to receive written comments from the public through February 28, 2010, after which it is expected to issue draft guidance.

While a few individuals and agencies have submitted comments, to date only one adhoc group of pharmaceutical industry representatives have submitted comments. That group is the the Social Media Working Group (SMWG), which has come together to "facilitate discussions with the Division of Drug Marketing, Advertising and Communications, industry associations, and other pharmaceutical manufacturers on social media issues. The SMWG includes representatives from the following companies: Amgen, Inc.; AstraZeneca LP; Bristol-Myers Squibb; Millennium Pharmaceuticals, Inc.; and sanofi-aventis U.S."

"Healthcare professionals, patients, caregivers and other consumers are increasingly interacting within online communities in which health-related topics are discussed," said the SMWG in its comments to the FDA. "However, this on-line health information is accompanied by serious concerns regarding source, quality, and credibility (Kunst, H., Groot, D., Latthe, P.M., Latthe, M., & Khan, K.S. (2002). Accuracy of information on apparently credible websites: Survey of five common health topics. 8MJ, 324, 581-582). Engaging in these online communities allows pharmaceutical manufacturers to interact with those healthcare professionals, caregivers, and consumers seeking health and product information when and where they are looking for it," said the SMWG. "As authoritative sources of medical product information and the conditions and diseases for which the products are used, it is appropriate that pharmaceutical manufacturers contribute to, and participate in, these communities in order to help ensure the accuracy and completeness of the information presented and discussed."

Some Questions/Topics to be Discussed

Can you speak a little about the Social Media Working Group - who it consists of, how it formed, and what its objectives are?

Why is it important for the pharmaceutical industry to participate in online media? In other words, what do pharmaceutical companies bring to social media that is unique?

In the absence of FDA guidance/regulation specific to the Internet, are there basic regulatory guidelines which companies should follow?

The working group proposed the inclusion of Terms of Use on social media sites under company control. Can you elaborate on what those Terms of Use might address with respect to enabling the industry's engagement in social media?

What recommendations would the working group like the FDA to consider in terms of how a company might consider responding to a visitor posting, on a company site, in which an off-label use of the company's product is mentioned?

What about a similar situation occurring on a third-party site hosting a discussion in which the company is engaged?

Given the real-time nature of online discussions, what proposals does the working group have for meeting the FDA requirement to submit promotional materials at time of first use?

Guest Bios

Craig M. Audet is Vice-President and Head of the US Regulatory Affairs Marketed Products Group at sanofi-aventis. In this role, he is responsible for four groups charged with developing and implementing regulatory strategies for prescription and OTC drugs, medical devices, and cosmetics in the areas of advertising and promotion, labeling, product defense, clinical trials, and product development and maintenance.

Prior to joining sanofi-aventis, Mr. Audet served as the Cardiovascular Global Therapeutic Area Leader at Pfizer, where he had worldwide regulatory responsibility for the company's cardiovascular drug product portfolio (Phase II-IV).

Mark Gaydos: As Senior Director, U.S. Regulatory Affairs Marketed Products at sanofi-aventis, Mr. Gaydos oversees the group responsible for developing and implementing regulatory strategies for the oncology, urology, and dermatology portfolios. Mr. Gaydos also serves as the regulatory lead on sanofi-aventis' Social Media Task Force, which is responsible for advancing the company's engagement in emerging digital media.

Prior to joining sanofi-aventis, Mr. Gaydos was Director of Worldwide Regulatory Strategy at Pfizer, supporting the Cardiovascular group. He has also held positions of increasing responsibility with Amgen, Block Drug Co., and Wyeth Consumer Healthcare (formerly Whitehall-Robins Healthcare).

Cynthia Phillips, B.S., M.B.A is currently Senior Director of Regulatory Labeling and Promotional Compliance at Millennium Pharmaceuticals, Inc. She has held similar positions at Shire HGT, Bristol-Myers Squibb and AstraZeneca.

Ms. Phillips began her pharmaceutical career as a sales representative with Merck over the past 26 years she has held a number of positions in the field including field marketing, business management and regulatory field staff. She has used this broad background to provide promotional regulatory advice and training to her organizations, specializing in CME, DTC and Internet activities, including social media. Ms. Phillips is a frequent speaker at industry conferences. Ms. Phillips received her B.S. in Management from Cardinal Stritch College and an MBA in eCommerce from West Chester University.